Sulfur Hexafluoride

1 INDICATIONS AND USAGE Echocardiography Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Ultrasonography of the Liver Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions. Ultrasonography of the Urinary Tract Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux.

6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Cardiopulmonary reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence ≥ 0.5%) are headache and nausea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary There are no data with Lumason use in pregnant women to inform any drug-associated risks. No adverse developmental outcomes were observed in animal reproduction studies with administration of sulfur hexafluoride lipid-type A microspheres in pregnant rats and rabbits during organogenesis at doses up to at least 10 and 20 times, respectively, the maximum human dose of 4.8 mL based on body surface area ( see Data ). In the U.S.

WARNING: SERIOUS CARDIOPULMONARY REACTIONS Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions ( 5.1 )] . Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions ( 5.1 )] . 5 WARNINGS AND PRECAUTIONS Cardiopulmonary reactions, including fatalities. Always have resuscitation equipment and trained personnel readily available ( 5.1 ) Hypersensitivity reactions. Serious acute hypersensitivity reactions have occurred in patients with no prior exposure to sulfur hexafluoride lipid-containing microsphere products, including patients with prior hypersensitivity reaction(s) to PEG ( 5.2 , 6 ) 5.1 Serious Cardiopulmonary Reactions Serious cardiopulmonary reactions, including fatalities have occurred uncommonly during or shortly following administration of ultrasound contrast agents, including Lumason. These reactions typically occurred within 30 minutes of administration. 4 CONTRAINDICATIONS Lumason is contraindicated in patients with known or suspected: Hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG) [see Warnings and Precautions ( 5.2 ) and Description ( 11 )] . Hypersensitivity to sulfur hexafluoride lipid microspheres or its components, such as polyethylene glycol (PEG) ( 4 )